Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
HTL-Strefa S.A.
This study aims to evaluate the safety of the use of the safety lancets: ergoLance and Acti-Lance in the prevention of NSI and to evaluate the user's opinion with regards to the handling characteristics of the medical devices.
The simulated use clinical study will involve healthcare professionals (HCPs) who routinely use safety lancets to collect blood samples and lay persons.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
(HCP evaluators only) - evaluators who routinely use safety lancets to collect capillary blood samples (prevention of the learning curve artifacts)
evaluators will be United States (US) residents
evaluators can read, write, and speak English
evaluators are at least 18 years old
evaluators are able to understand and provide signed consent for the study
evaluators are willing to comply with the study protocol, including being willing to answer questions and complete questionnaires.
evaluators have no concerns about the ability to perform the simulated skin pricking.
Lay person evaluators will have a diverse range of ages (18+ years), socioeconomic statuses, and race/ethnic backgrounds. UL-Wiklund will recruit some lay person evaluators with reduced vision and dexterity. Users without safety lancet experience may also be included in this simulated clinical use study.
You may not be if
HCPs:
They do not routinely use safety lancets to collect capillary blood samples,
They cannot read, write, and speak English,
They or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or
They have participated in a product evaluation or marketing study involving safety lancets within the last six months
Lay people:
They cannot read, write, and speak English,
They or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or
They have participated in a product evaluation or marketing study involving safety lancets within the last six months
Clareo Health | Simulated Clinical Use Testing on Safety Lancets (Test A)
